A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT06607185
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY4066434. — DRUG
    Administered orally.
  • Cetuximab — DRUG
    Administered intravenously.
  • Nab paclitaxel — DRUG
    Administered intravenously.
  • Gemcitabine — DRUG
    Administered intravenously.
  • Oxaliplatin — DRUG
    Administered intravenously.
  • Leucovorin — DRUG
    Administered intravenously.
  • Irinotecan — DRUG
    Administered intravenously.
  • 5Fluorouracil — DRUG
    Administered intravenously.
  • Carboplatin — DRUG
    Administered intravenously.
  • Cisplatin — DRUG
    Administered intravenously.
  • Pemetrexed — DRUG
    Administered intravenously.
  • Pembrolizumab — DRUG
    Administered intravenously.

Study Details

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

Key Dates

Start date
Oct 21, 2024
Status verified
May 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
750 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LY4066434 Monotherapy Dose Escalation
    Escalating doses of LY4066434 administered orally.
  • Experimental: LY4066434 Dose Optimization
    LY4066434 administered orally either alone or with another investigational agent.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: During the first cycle of LY4066434 treatment (up to 28 days) ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Mayo ClinicPhoenixArizona85054-
City of HopeDuarteCalifornia91010-
University of California, Los Angeles (UCLA)Santa MonicaCalifornia90404-
Yale University School of Medicine - Yale Cancer CenterNew HavenConnecticut06520-8028-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
Indiana University (IU)IndianapolisIndiana46202-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546-
Columbia UniversityNew YorkNew York10032-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Sarah Cannon Research Institute/SCRINashvilleTennessee37203-
SCRI Oncology PartnersNashvilleTennessee37203-
University of Texas SouthwesternDallasTexas75244-
MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Swedish Cancer Institute (SCI)SeattleWashington98104-

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University of Alabama at Birmingham· Birmingham, ALMayo Clinic· Phoenix, AZCity of Hope· Duarte, CAUniversity of California, Los Angeles (UCLA)· Santa Monica, CAYale University School of Medicine - Yale Cancer Center· New Haven, CTThe University of Chicago Medical Center (UCMC)· Chicago, IL

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